Trial Condition(s):
Endometriosis
Daily practice treatment and Influence of Visanne on the patient assessment of quality of life (DIVA)
Bayer Identifier:
16108
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
The study aims to collect data on the influence of a treatment with Visanne (Dienogest 2mg/d) on the Endometriosis related quality of life. These data will be collected using a special patient questionnaire (Endometriosis Health Profile 5, EHP-5). The study will also be used to describe the basic disease status and demographic characteristics of patients searching treatment by a gynecologist because of their endometriosis. In addition, the study will give insight into the typical diagnostic measures the physicians in different countries are using in the field of endometriosis.
Inclusion Criteria
- Female patients older than 18 years of age - Clinical or laparoscopic diagnosis of endometriosis - Having endometriosis related pain as leading symptom - Decision taken by physician to prescribe Visanne - Signed Informed Consent Form
Exclusion Criteria
- Contraindications listed in the local summary of product characteristics (SPC) have to be considered.
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Investigative Site Many Locations, Russia | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Ukraine | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Belarus | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Kazakhstan | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Egypt | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Kuwait | Status Completed | Contact Us: E-mail: c[email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Saudi Arabia | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Jordan | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Lebanon | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Qatar | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, United Arab Emirates | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Study to characterize patients treated with Visanne for their Endometriosis under real-life practice conditions and evaluate their quality of life at baseline and after 6 months of treatment with Visanne.
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- Percentage of patients, who show an improvement of the EHP-5 itemsTimeframe: after 6 months of treatment
- Mean changes of EHP-5 items by using scores for pre-defined categoriesTimeframe: after 6 months of treatment
Secondary Outcome
- Baseline demographic characteristics and disease status of patients with endometriosis treated with VisanneTimeframe: Baseline
- Patient reported severity of endometriosis related painTimeframe: Baseline and after 6 months of treatment
- Reasons for treatment discontinuationTimeframe: after 6 months of treatment
- Safety variables will be summarized using descriptive statistics based on adverse events collectionTimeframe: after 6 months of treatment
Additional Information
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